Alsuwaidan Salem, Memish Ziad A, Alaklobi Faisal, Khan Kholood, Alajami Hamdan N
Research and Innovation Center, King Saud Medical City, Ministry of Health, Riyadh, Saudi Arabia.
College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.
Ann Med Surg (Lond). 2021 Oct;70:102867. doi: 10.1016/j.amsu.2021.102867. Epub 2021 Sep 16.
Hydroxychloroquine (HCQ) and chloroquine were found to have positive results in some non-randomized clinical trials with more benefit in decreasing the viral load of COVID-19. HCQ is a lysosomotropic and lipophilic drug that can penetrate cell membranes, and accumulates in the acidic lysosomes. The high concentration of alkaline HCQ increases the pH in lysosomes from the normal levels of 4.7-4.8 to 6 which leads to inhibition of lysosomes functions and thus, prevents the entry of coronavirus into cells.
The main aim of this study is to find out the appropriateness of using HCQ in asymptomatic/mildly symptomatic COVID-19 positive patients in an attempt to reduce the development of signs and symptoms of COVID-19 and severe disease.
Randomized selection, open-label trial to evaluate the efficacy of HCQ for patients presenting with asymptomatic COVID-19 upon diagnosis. Cases that met the inclusion criteria were divided into two arms [102 subjects to take HCQ (a loading dose of 400 mg twice daily given orally, followed by a maintenance dose of 200 mg twice daily for 4 days), and 100 subjects were used as a control group]. A follow-up for all the participants on daily basis for 14 days for any signs and symptoms (fever, cough, and shortness of breath). The main variables are action profile (represented by Area under the curve (AUC) for fever, cough, and shortness of breath statistically analyzed to differentiate between the two groups.
Data in this study showed that HCQ was effective in reducing body temperature from the first day to the fifth day; this positive effect was significant with (p < 0.001) compared with subjects who didn't receive HCQ. While there was no significant effect on cough or Shortness of breath.
The recommendation of this study is to utilize HCQ to all subjects with asymptomatic COVID-19 infection providing that these subjects are within the inclusion criteria of this study. There was no adverse drug reaction observed for HCQ on daily follow-up.
在一些非随机临床试验中发现，羟氯喹（HCQ）和氯喹有积极效果，在降低新冠病毒病（COVID-19）病毒载量方面益处更多。HCQ是一种亲溶酶体和亲脂性药物，能穿透细胞膜，并在酸性溶酶体中蓄积。高浓度的碱性HCQ将溶酶体的pH值从正常的4.7 - 4.8提高到6，这导致溶酶体功能受到抑制，从而阻止冠状病毒进入细胞。
本研究的主要目的是确定在无症状/症状轻微的COVID-19阳性患者中使用HCQ以试图减少COVID-19体征和症状以及严重疾病发展的适宜性。
随机选择、开放标签试验，以评估HCQ对诊断为无症状COVID-19患者的疗效。符合纳入标准的病例分为两组[102名受试者服用HCQ（口服负荷剂量400mg，每日两次，随后维持剂量200mg，每日两次，共4天），100名受试者作为对照组]。对所有参与者进行为期14天的每日随访，观察任何体征和症状（发热、咳嗽和呼吸急促）。主要变量是作用曲线（由发热、咳嗽和呼吸急促的曲线下面积（AUC）表示），通过统计学分析以区分两组。
本研究数据显示，HCQ从第一天到第五天有效降低体温；与未接受HCQ的受试者相比，这种积极效果显著（p < 0.001）。而对咳嗽或呼吸急促没有显著影响。
本研究的建议是，对于所有无症状COVID-19感染且符合本研究纳入标准的受试者使用HCQ。在每日随访中未观察到HCQ有药物不良反应。
